Medical Information

Ribociclib is a selective CDK4/6 inhibitor, which is mainly used to treat advanced or metastatic breast cancer with hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-). This drug significantly prolongs the progression free survival of patients by blocking key cell cycle regulatory proteins, and its clinical efficacy has been validated by multiple international studies.

1. Basic information of drugs

(1) Drug category: Raboxetine belongs to cyclin dependent kinase 4/6 (CDK4/6) inhibitors, which block tumor cell proliferation cycle by inhibiting Rb protein phosphorylation.

(2) Research and Development Background:  it was first approved by the FDA in March 2017 and has been approved for use in over 80 countries worldwide.

2. Main therapeutic indications

(1) Combined endocrine therapy: combined with aromatase inhibitor as the first-line treatment for HR+/HER2 postmenopausal advanced breast cancer.

(2) Extended indications: It will be approved for the treatment of male breast cancer in 2021, becoming the first CDK4/6 inhibitor to cover this population.

3. Clinical treatment effect

(1) Progression free survival: The MONALEESA-2 study showed a median PFS of 25.3 months in combination with letrozole, an increase of 11 months compared to the control group.

(2) Overall survival benefit: The MONALEESA-7 trial confirmed that combined endocrine therapy prolonged OS to 58.7 months and reduced the risk of death by 29%.

(3) Objective response rate: The ORR of first-line treatment is 40.7%, and the disease control rate can reach over 80%.

4. Special treatment advantages

(1) Convenient administration: once daily oral plan, with a cycle design of 21 days of medication and 7 days of rest.

(2) Safety features: Neutropenia is the main adverse reaction, but can be managed through dose adjustment.

(3) Quality of life: significantly delaying the time required for chemotherapy and achieving outstanding results in maintaining patients' quality of life.